News

New data on Hengrui Pharma and Kailera Therapeutics’ investigational oral GLP-1 have validated the late-stage weight loss asset and paved the road for a regulatory submission in China, but analysts pointed to high rates of nausea and vomiting that could challenge the ongoing U.S. study.
FEATURED STORIES
Molecular glue degraders are gaining traction in the clinic as well as funding from Big Pharma, with their potential to treat previously “undruggable” cancers and immunological diseases. Here are five clinical programs worth keeping an eye on.
Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
FDA
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
THE LATEST
Aera Therapeutics emerged from stealth mode Thursday with a platform based on the work of Feng Zhang, Ph.D. and ex-Alnylam executive Akin Akinc at the helm.
Skye Bioscience, Inc. (OTCQB: SKYE) (“Skye” or the “Company”), a pharmaceutical company developing a proprietary, synthetic cannabinoid derivative to treat glaucoma, has appointed Dr. Deborah Charych to its board of directors effective immediately.
Taxpayer-funded research in biosciences will no longer sit behind paywalls. Instead, all of this data will be publicly available for no cost.
Spanish drugmaker Grifols announced a comprehensive plan Wednesday to improve its efficiency and cost-effectiveness – a move that will reportedly cost some 2,000 U.S. jobs.
Arrowhead Pharmaceuticals has gained full rights to ARO-PNPLA3, formerly JNJ-75220795, the company announced Wednesday.
Genome engineering company Replay and the MD Anderson Cancer Center have joined forces to launch Syena, an oncology product company.
Biogen’s 2022 fourth-quarter and full-year report comes the day after an additional warning on the company’s first Alzheimer’s drug came to light.
Curie.Bio launched this week with $520 million to take early startups from ground zero through Series A funding.
Enveda’s primary R&D efforts will focus on inflammation, fibrosis and neurosensory biology within the GI, dermatology and pulmonary therapeutic areas.
The COVID-19 research collaboration between Vir Biotechnology and GSK has largely come to an end, as Vir announced Monday it would be going it alone or with other partners.